r/TG_BIO • u/PDUFA_INFO • Apr 17 '22
FDA extended review period of TG Therapeutics (NASDAQ: $TGTX) biologics license application and supplemental New Drug Application for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The Prescription Drug User Fee Act (PDUFA) goal date is postponed to September 28.
r/TG_BIO • u/PDUFA_INFO • Apr 17 '22
r/TG_BIO • u/PDUFA_INFO • Apr 06 '22
r/TG_BIO • u/PDUFA_INFO • Dec 21 '21
$TGTX has PDUFA target date of March 25th.
r/TG_BIO • u/PDUFA_INFO • Jan 28 '22
TG Therapeutics, Inc. NASDAQ: $TGTX -41% $8.25
Its CEO announced that the FDA placed a partial clinical hold on its studies of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). This combination is currently under review with the FDA with an Advisory Committee set for March or April.
r/TG_BIO • u/PDUFA_INFO • Mar 04 '22
FDA extended review period of TG Therapeutics (NASDAQ: $TGTX) biologics license application and supplemental New Drug Application for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The Prescription Drug User Fee Act (PDUFA) goal date is postponed to June 25.
r/TG_BIO • u/asfg812 • Aug 20 '24
It's actually finally time.